Evaluation of the Added Value of a Large Molecular Profiling Panel Versus a Limited Molecular Profiling Panel in Advanced Solid Tumors.

Brief description of study

The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to
compare the clinical relevance of a large Next-generation sequencing (NGS) panel
(FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients
with advanced solid tumors.

This study will allow adapting the therapeutic management of these patients, if needed, by
giving them recommended therapies (commercialized or in ongoing clinical trials), based on
the recommendations of the Molecular Tumor Board (MTB).

Detailed Study Description

The genetic and immunologic profile of the tumor will be determined from archival or fresh
collected tumor sample.

For each patient, the tumor genomics data will be reviewed, at time of documented progressive
disease, independently by a dedicated MTB to make a recommendation of therapy for a given
patient based on its molecular profile. First, the genomics data issued from the panel
defined by the randomization will be reviewed and recommended therapy resulting from
randomization will be revealed to the Investigator. If a recommended therapy can be
identified, this therapy will be recommended.

If none recommended therapy can be identified, the 2nd panel performed will then be reviewed.

In case of confirmed clinical or radiological progression (at Investigator's discretion)
and/or unacceptable toxicity as per Investigator judgment during the line of therapy
recommended by the MTB, the results of the second panel will be reviewed by MTB. Based on all
genomics data available (i.e. randomized and 2nd panels), the MTB will recommend other
treatment options. All results will be disclosed to Investigator in order to offer other
treatment options.